Type 2 Diabetes MellitusPhase 2NCT02004886

A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)

A Phase 2 study testing MK-0893 and Metformin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will reduce 24-hour weighted mean glucose (WMG) significantly more than placebo. Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: MK-0893 and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: No sites listed yet
Study dates: 11 Aug 2006to 7 Feb 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes
Not currently on antihyperglycemic agent (AHA) or AHA monotherapy (not to include treatment with insulin or thiazolidinediones [i.e., peroxisome proliferator activated receptor-gamma, PPARγ agents])
male or a female of non-childbearing potential. Women must be postmenopausal or premenopausal and documented surgically sterilized
A body mass index (BMI) that is > 20 and ≤ 40 kg/m2

Who cannot join

History of type 1 diabetes or assessed by the investigator as possibly having type 1 diabetes
History of ketoacidosis; clinically unstable or rapidly progressive diabetic retinopathy, nephropathy, neuropathy
Treatment for diabetes within 3 months of study participation with combination anti-hyperglycemic therapy, insulin or thiazolidinediones (e.g., rosiglitazone or pioglitazone)
oral corticosteroid medications within 2 weeks prior to study participation, or requires digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies
History of acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
History of gastrointestinal problems or disorders or extensive bowel or gastric surgery

Show all 11Show fewer

History of significant or unstable cardiovascular disease
History of neoplastic disease
History of hepatic disease
History of seizures, epilepsy or other neurologic disease
History of myelodysplastic or pre-leukemic disorders or other severe hematological disorder

About this study

Official title: A Multi-Center, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Panel Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Patients With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: MK-0893, Metformin, Placebo
Keywords: Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Therapeutic Uses, Pharmacologic Actions, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Metformin
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-0893Drug
10 mg and 100 mg tablets
MetforminDrug
Also called Glucophage, Glucophage XR, Glumetza, Fortamet
500 mg metformin tablets
PlaceboDrug
Placebo tablets matching MK-0893
PlaceboDrug
Placebo tablets matching metformin

Study groups in NCT02004886
Study group	Role	What they receive
MK-0893 (40 mg)	Experimental	MK-0893 40-mg q.d. (quaque die, once daily) group will receive MK-0893 40-mg tablets (after loading dose with 160 mg) and matching placebo to metformin and matching placebo to MK-0893. Receives: Drug: MK-0893; Drug: Placebo
MK-0893 (120 mg)	Experimental	MK-0893 at 120 mg q.d. group will receive MK-0893 120 mg q.d. tablets (after loading dose of 500 mg on Day 1) and matching placebo tablets to metformin and matching placebo to MK-0893 Receives: Drug: MK-0893; Drug: Placebo
Metformin (2000 mg)	Active comparator	Metformin taken orally, 500 mg tablets, Day 1 to Day 6: 500 mg b.i.d. (bis in die, twice daily), Day 7 to Day 13: 1000 mg in the morning and 500 mg in the evening, and Day 14 to Day 28: 1000 mg. b.i.d. and matching placebo to MK-0893. Receives: Drug: Metformin; Drug: Placebo
Placebo	Placebo comparator	Placebo tablets matching the MK-0893 and placebo tablets matching metformin. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period.
Measured: Baseline and Week 4
Number of Participants Experiencing an Adverse Event (AE)
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Measured: Up to 42 days
Number of Participants Discontinuing Study Treatment Due to an AE
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Measured: Up to 28 days

Secondary outcomes (8)

Change From Baseline in Fasting Plasma Glucose (FPG)
Plasma Glucose levels were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Measured: Baseline and Week 4
Change From Baseline in Fructosamine at Week 4
Fructosamine levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Measured: Baseline and Week 4
Change From Baseline in Fasting C-peptide at Week 4
Fasting C-peptide levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Measured: Baseline and Week 4
Change From Baseline in Fasting Insulin at Week 4
Fasting insulin levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Measured: Baseline and Week 4
Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4
2-hour post-prandial glucose excursion is the change in glucose concentration in the blood 2 hours after a meal. Change from baseline in 2-hour post-prandial glucose excursion at Week 4 is defined as Week 4 minus baseline.
Measured: Baseline and Week 4
Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4
Blood samples collected for glucose 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for Glucose was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Measured: Baseline and Week 4
Change From Baseline in 3-hour AUC for C-peptide at Week 4
Blood samples were collected for C-peptide 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for C-peptide was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Measured: Baseline and Week 4
Change From Baseline in 3-hour Insulin Total AUC at Week 4
Blood samples were collected for insulin 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour Insulin Total AUC was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Aug 20067 Feb 2007

First posted9 Dec 2013 (estimated)
Study start11 Aug 2006
Primary completion7 Feb 2007
Study completion7 Feb 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02004886
Sponsor's protocol ID: 0893-005
Status last verified: Aug 2018
First submitted: 3 Dec 2013
Last updated: 5 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Panel Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02004886
Acronym / sponsor ID: 0893-005
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Therapeutic Uses, Pharmacologic Actions, Molecular Mechanisms of Pharmacological Action
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 11 Aug 2006 (actual)
Primary completion: 7 Feb 2007 (actual)
Study completion: 7 Feb 2007 (actual)
First posted: 9 Dec 2013 (estimated)
Results: Posted 18 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
MK-0893 (40 mg)	Experimental	Drug: MK-0893, Drug: PlaceboMK-0893 40-mg q.d. (quaque die, once daily) group will receive MK-0893 40-mg tablets (after loading dose with 160 mg) and matching placebo to metformin and matching placebo to MK-0893.
MK-0893 (120 mg)	Experimental	Drug: MK-0893, Drug: PlaceboMK-0893 at 120 mg q.d. group will receive MK-0893 120 mg q.d. tablets (after loading dose of 500 mg on Day 1) and matching placebo tablets to metformin and matching placebo to MK-0893
Metformin (2000 mg)	Active comparator	Drug: Metformin, Drug: PlaceboMetformin taken orally, 500 mg tablets, Day 1 to Day 6: 500 mg b.i.d. (bis in die, twice daily), Day 7 to Day 13: 1000 mg in the morning and 500 mg in the evening, and Day 14 to Day 28: 1000 mg. b.i.d. and matching placebo to MK-0893.
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablets matching the MK-0893 and placebo tablets matching metformin.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Type 2 diabetes
Not currently on antihyperglycemic agent (AHA) or AHA monotherapy (not to include treatment with insulin or thiazolidinediones [i.e., peroxisome proliferator activated receptor-gamma, PPARγ agents])
male or a female of non-childbearing potential. Women must be postmenopausal or premenopausal and documented surgically sterilized
A body mass index (BMI) that is > 20 and ≤ 40 kg/m2

Key exclusion criteria (11 listed)

History of type 1 diabetes or assessed by the investigator as possibly having type 1 diabetes
History of ketoacidosis; clinically unstable or rapidly progressive diabetic retinopathy, nephropathy, neuropathy
Treatment for diabetes within 3 months of study participation with combination anti-hyperglycemic therapy, insulin or thiazolidinediones (e.g., rosiglitazone or pioglitazone)
oral corticosteroid medications within 2 weeks prior to study participation, or requires digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies
History of acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-089310 mg and 100 mg tablets	Drug	MK-0893 (120 mg), MK-0893 (40 mg)
MetforminAlso: Glucophage, Glucophage XR, Glumetza, Fortamet500 mg metformin tablets	Drug	Metformin (2000 mg)
PlaceboPlacebo tablets matching MK-0893	Drug	MK-0893 (120 mg), MK-0893 (40 mg), Metformin (2000 mg), Placebo
PlaceboPlacebo tablets matching metformin	Drug	MK-0893 (120 mg), MK-0893 (40 mg), Placebo

Primary outcome

Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
Time frame: Baseline and Week 4
Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period.
Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to 42 days
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Number of Participants Discontinuing Study Treatment Due to an AE
Time frame: Up to 28 days
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.

8 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline and Week 4
Change From Baseline in Fructosamine at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Fasting C-peptide at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Fasting Insulin at Week 4
Time frame: Baseline and Week 4
Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4
Time frame: Baseline and Week 4
Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4
Time frame: Baseline and Week 4
Change From Baseline in 3-hour AUC for C-peptide at Week 4
Time frame: Baseline and Week 4
Change From Baseline in 3-hour Insulin Total AUC at Week 4
Time frame: Baseline and Week 4

Results and safety

Results posted to the registry on 18 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-0893 (40 mg)	19	18
MK-0893 (120 mg)	18	17
Metformin (2000 mg)	18	18
Placebo	19	19

Primary outcome: Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4

Time frame: Baseline and Week 4. Least squares mean (95% Confidence Interval). Unit: mg/dL

Measure	MK-0893 (40 mg) n = 18	MK-0893 (120 mg) n = 17	Metformin (2000 mg) n = 18	Placebo n = 19
Value	-37.9 (-47.1 to -28.8)	-65.7 (-74.8 to -56.5)	-38.1 (-47.0 to -29.2)	-12.0 (-20.7 to -3.4)

MK-0893 (40 mg) vs Placebo: Mean Difference (Final Values): -25.9 (95% CI -38.4 to -13.3), p <0.001, ANCOVA
MK-0893 (120 mg) vs Placebo: Median Difference (Final Values): -53.6 (95% CI -66.1 to -41.1), p <0.001, ANCOVA
Metformin (2000 mg) vs Placebo: Mean Difference (Final Values): -26.0 (95% CI -38.4 to -13.6), p <0.001, ANCOVA

Population analysed: Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.

Primary outcome: Number of Participants Experiencing an Adverse Event (AE)

Time frame: Up to 42 days. Number. Unit: Number of Participants

Measure	MK-0893 (40 mg) n = 19	MK-0893 (120 mg) n = 18	Metformin (2000 mg) n = 18	Placebo n = 19
Value	3	7	9	8

Population analysed: Safety Population included all randomized participants who initiated study therapy.

Primary outcome: Number of Participants Discontinuing Study Treatment Due to an AE

Time frame: Up to 28 days. Number. Unit: Number of Participants

Measure	MK-0893 (40 mg) n = 19	MK-0893 (120 mg) n = 18	Metformin (2000 mg) n = 18	Placebo n = 19
Value	0	1	0	0

Population analysed: Safety Population included all randomized participants who initiated study therapy.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 42 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-0893 (40 mg)	0 of 19 (0%)	3 of 19 (15.8%)	Not reported
MK-0893 (120 mg)	0 of 18 (0%)	7 of 18 (38.9%)	Not reported
Metformin (2000 mg)	0 of 18 (0%)	9 of 18 (50%)	Not reported
Placebo	0 of 19 (0%)	8 of 19 (42.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-0893 and Metformin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4 (time frame: Baseline and Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02004886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.